For COVID-Impacted Studies, US FDA Loosens Video Conferencing But Tightens Home Infusion Guidance
Also, use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, FDA's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.
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In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.
Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.
Clinical Trials: Industry Navigating Alternative Ways Of Delivering Investigational Drugs During Pandemic
New approaches include delivering study drug from a clinical site directly to a patient’s house through a courier service, as well as use of drones and automated dispensing units; future trials could see a mix of delivery approaches.